美国FDA批准辉瑞和Merck两款Covid治疗药物，让病人在生病住院前可以在家服用。加拿大批准辉瑞抗病毒新药。
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土地平旷，屋舍俨然，有良田、美池、桑竹之属。阡陌交通，鸡犬相闻。其中往来种作，男女衣着，悉如外人。
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是的, 如果遵医嘱正当服用羟氯喹, 本来是很安全的。但是如果搜一下, 也会被搜出一长串副作用。这是由于制药业的严谨。药物要遵医嘱, 有疑虑要问医生问药剂师的专业意见。
贵圈
政府都对党
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世卫组织数据库
Fluvoxamine contains the active ingredient(s): Fluvoxamine.
Result is presented for the active ingredient(s).
Total number of records retrieved: 10306.
ivermectin contains the active ingredient(s): Ivermectin.
Result is presented for the active ingredient(s).
Total number of records retrieved: 5697.、
Fluvoxamine contains the active ingredient(s): Fluvoxamine.
Result is presented for the active ingredient(s).
Total number of records retrieved: 10306.
ivermectin contains the active ingredient(s): Ivermectin.
Result is presented for the active ingredient(s).
Total number of records retrieved: 5697.、
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UK authorizes Merck antiviral pill, 1st shown to treat COVID
By MATTHEW PERRONE and MARIA CHENGtoday
1 of 2
FILE - This undated image provided by Merck & Co. shows their new antiviral medication against COVID-19. Britain has granted a conditional authorization to Merck's coronavirus antiviral, the first pill shown to successfully treat COVID-19. It is the first country to OK the treatment, although it was not immediately clear how quickly the pill would be available. (Merck & Co. via AP, File)
LONDON (AP) — Britain granted conditional authorization on Thursday to the first pill shown to successfully treat COVID-19 so far. It also is the first country to OK the treatment from drugmaker Merck, although it wasn’t immediately clear how quickly the pill would be available.
The pill was licensed for adults 18 and older who have tested positive for COVID-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate COVID-19 would take four pills of the drug, known molnupiravir, twice a day for five days.
An antiviral pill that reduces symptoms and speeds recovery could prove groundbreaking, easing caseloads on hospitals and helping to curb outbreaks in poorer countries with fragile health systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.
Molnupiravir is also pending review with regulators in the U.S., the European Union and elsewhere. The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness in late November.
Initial supplies will be limited. Merck has said it can produce 10 million treatment courses through the end of the year, but much of that supply has already been purchased by governments worldwide.
In October, U.K. officials announced they secured 480,000 courses of molnupiravir and expected thousands of vulnerable Britons to have access to the treatment this winter via a national study.
“Today is a historic day for our country, as the U.K. is now the first country in the world to approve an antiviral that can be taken at home for COVID-19,” British health secretary Sajid Javid said.
“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible,” he said in a statement, referring to the U.K.’s National Health Service. Doctors said the treatment would be particularly significant for people who don’t respond well to vaccination.
Merck and partner Ridgeback Biotherapeutic have requested clearance for the drug with regulators around the world for adults with early cases of COVID-19 who are at risk for severe disease or hospitalization. That’s roughly the same group targeted for treatment with infused COVID-19 antibody drugs, the standard of care in many countries for patients who don’t yet require hospitalization.
Merck announced preliminary results in September showing its drug cut hospitalizations and deaths by half among patients with early COVID-19 symptoms. The results haven’t yet been peer reviewed or published in a scientific journal.
The company also didn’t disclose details on molnupiravir’s side effects, except to say that rates of those problems were similar between people who got the drug and those who received dummy pills.
The drug targets an enzyme the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow its ability to spread and take over human cells. That genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumors.
Britain’s Medicines and Healthcare products Regulatory Agency said molnupiravir’s ability to interact with DNA and cause mutations had been studied “extensively” and that it wasn’t found to pose a risk to humans.
“Studies in rats showed that (molnupiravir) may cause harmful effects to the unborn offspring, although this was at doses which were higher than those that will be given to humans, and these effects were not observed in other animals,” the agency said in an email.
In company trials, both men and women were instructed to either use contraception or abstain from sex. Pregnant women were excluded from the study. Merck has stated that the drug is safe when used as directed.
Molnupiravir was initially studied as a potential flu therapy with funding from the U.S. government. Last year, researchers at Emory University decided to repurpose the drug as a potential COVID-19 treatment. They then licensed the drug to Ridgeback and partner Merck.
Last week, Merck agreed to allow other drugmakers to make its COVID-19 pill, in a move aimed at helping millions of people in poorer countries get access. The Medicines Patent Pool, a U.N.-backed group, said Merck will not receive royalties under the agreement for as long as the World Health Organization deems COVID-19 to be a global emergency.
But the deal was criticized by some activists for excluding many middle-income countries capable of making millions of treatments, including Brazil and China.
Still, experts commended Merck for agreeing to widely share its formula and promising to help any companies who need technological help in making their drug — something no coronavirus vaccine producers have agreed to.
“Unlike the grotesquely unequal distribution of COVID-19 vaccines, the poorest countries will not have to wait at the back of the queue for molnupiravir,” said Dr. Mohga Kamal-Yanni, a senior health adviser to the People’s Vaccine Alliance. Fewer than 1% of the world’s COVID-19 vaccines have gone to poor countries and experts hope easier-to-dispense treatments will help them curb the pandemic.
Merck previously announced licensing deals with several Indian makers of generic drugs to manufacture lower-cost versions of molnupiravir for developing countries.
The U.S. has agreed to pay roughly $700 per course of the drug for about 1.7 million treatments. Merck says it plans to use a tiered pricing strategy for developing countries. A review by Harvard University and King’s College London estimated the drug costs about $18 to make each 40-pill course of treatment.
While other treatments have been cleared to treat COVID-19, including steroids and monoclonal antibodies, those are administered by injection or infusion and are mostly used in hospitals and other health care facilities.
LONDON (AP) — Britain granted conditional authorization on Thursday to the first pill shown to successfully treat COVID-19 so far. It also is the first country to OK the treatment from drugmaker Merck, although it wasn't immediately clear how quickly the pill would be available.
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辉瑞正在做实验的治疗药物
The pill, still known by its experimental name PF-07321332, is what's known as a protease inhibitor.
www.cnn.com
The pill, still known by its experimental name PF-07321332, is what's known as a protease inhibitor.
Pfizer says its experimental pill reduces risk of hospitalization, death from Covid-19 | CNN
Drugmaker Pfizer said Friday its experimental pill designed to fight coronavirus reduced the risk of hospitalization and death for high-risk patients taking part in a trial of the drug.
廊坊头条
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这儿有一个辉瑞的中文的：
辉瑞实验数据
辉瑞周五公布了对 775 名成年人的研究的初步结果。 与服用假药丸的患者相比，服用该公司药物和另一种抗病毒药物的患者在一个月后的住院或死亡综合率降低了 89%。 服用该药的患者中只有不到 1% 需要住院治疗，并且没有人死亡。 在对照组中，7% 的人住院，7 人死亡。
辉瑞首席科学官 Mikael Dolsten 博士在接受采访时说：“我们希望我们有一些非凡的东西，但你很少看到伟大的药物具有近 90% 的疗效和 100% 的死亡保护。”
辉瑞宣布：抗新冠口服药死亡风险降低近90% - 人在温哥华网 VanPeople.com
辉瑞公司周五宣布，其针对 COVID-19的实验性抗病毒药丸将住院率和死亡率降低了近 90%。辉瑞表示，将要求 FDA 和国际监管机构尽快批准其药丸。专家之前根据该药的实验强度，已
info.vanpeople.com
辉瑞实验数据
辉瑞周五公布了对 775 名成年人的研究的初步结果。 与服用假药丸的患者相比，服用该公司药物和另一种抗病毒药物的患者在一个月后的住院或死亡综合率降低了 89%。 服用该药的患者中只有不到 1% 需要住院治疗，并且没有人死亡。 在对照组中，7% 的人住院，7 人死亡。
辉瑞首席科学官 Mikael Dolsten 博士在接受采访时说：“我们希望我们有一些非凡的东西，但你很少看到伟大的药物具有近 90% 的疗效和 100% 的死亡保护。”
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Are we turning the corner on Covid-19 treatments?
Covid-19 treatments are key to living with the virus. Here’s where we’re at.By Kelsey Piper Nov 11, 2021, 9:00am EST
Stephanie Keith/Bloomberg via Getty Images
When the vaccines against Covid-19 first started rolling out less than a year ago, there was widespread hope that it signaled the beginning of the end of the pandemic. As we head into another winter, however, things are much more uncertain than many people had hoped: As much as we might want to put the pandemic behind us, the delta surge and vaccine hesitancy have ensured that Covid-19 has lingered.
But there’s another new development on the horizon that, in combination with vaccines, might really be a game changer.
In recent months, researchers have made some advances in figuring out how to treat Covid-19 once you’ve contracted it. Of particular promise are medications available in a form that should be especially useful in the fight against the virus: pills. Pills are easy to store and ship, making them a more feasible option for worldwide distribution, and they don’t tax already overloaded hospital resources during a surge.
To understand why the development of anti-Covid pills is a big deal, think about how we’ve been able to treat Covid-19 thus far. In the nearly two years since this coronavirus started spreading, we’ve learned a lot about how to care for patients who are sick enough to require hospital care. Cheap, widely available drugs such as dexamethasone have substantially reduced the hospital mortality rate for severe Covid-19.
But there are fewer options for sick people who haven’t been hospitalized. The one outpatient treatment authorized for emergency use and widely available in the US is monoclonal antibodies, which work quite well but must be administered as either a single IV infusion or a series of four shots in a medical setting.
Uptake of monoclonal antibodiesreportedly isn’t as high as it should be, and the treatment itself, while free to US patients, is pricey, costing the US government $2,100 per dose.
So as effective as monoclonal antibodies have been, there’s still a large void in our early treatment arsenal. When the virus surges in an area, hospitals get overwhelmed, meaning that people who end upneeding treatment might not get it. Meanwhile, people with mild to moderate cases are told to stay home, where they have very few options.
The lack of good early treatments for Covid-19 has led to high demand for drugs that have gained adherents but probably don’t help all that much, from hydroxychloroquine to metformin to ivermectin. The effort to figure out how and whether those treatments work has been marred by widespread fraud in published research investigating them.
But there’s finally been some real progress on identifying Covid-19 treatments that not only are highly effective but also available for Covid-19 sufferers to take at home.
Fighting Covid-19 with a pill
One pill that’s been shown to be effective against the disease wasn’t even made to fight Covid-19.Fluvoxamine is a cheap, generic antidepressant that’s been around since the 1990s. It also appears to reduce hospitalizations and deaths by Covid-19 by up to 30 percent, according to the results of a randomized, controlled trial, the initial findings of which I reported on back in August. Results from the so-called TOGETHER study, which tested fluvoxamine and some other treatments, were recently published in The Lancet medical journal.
How does fluvoxamine work in the case of Covid-19? Researchers’ best guess is that it modulates the body’s inflammatory response and reduces lung damage as the immune system fights off the coronavirus.
A 30 percent reduction in hospitalizations and deaths may not strike you as particularly high, but the drug is cheap (only $4 per dose) and has a demonstrated track record of safety (it’s FDA approved), which should strengthen the case for adding it to the global arsenal in the fight against the pandemic.
Despite encouraging trial results and a great safety profile, the National Institutes of Health’s treatment guidelines for fluvoxamine haven’t been updated since April, and the drug isn’t widely prescribed or recommended for Covid-19 patients. Doctors can make the call to prescribe fluvoxamine as an off-label treatment, but many might be reluctant to do so until the drug’s official guidelines incorporate evidence from large, reputable clinical studies demonstrating its efficacy. Now that the TOGETHER results have been published, though, doctors might be more willing to write those prescriptions.
An even more promising pill is Merck’s molnupiravir. Unlike fluvoxamine, it’s not already FDA approved, but it’s also repurposed after a fashion: Merck began developing the antiviral as an influenza treatment. It’s taken as a batch of up to four pills, twice a day for five days.
In Merck’s studies, molnupiravir reduced Covid-19 hospitalizations and deaths by about half. The UK granted the drug “conditional authorization” last week; the FDA has been reviewing the data since mid-October and will hold a hearing to discuss the data on November 30.
The US government has committed to purchasing 1.7 million courses of the drug for about $700 apieceonce it’s approved or authorized for emergency use. Merck has licensed the generic manufacturing of molnupiravir at a much, much cheaper price in more than 100 developing countries, and the success of that program will be key for molnupiravir to make a difference worldwide.
Finally, Pfizer’s Paxlovid is a little farther away from widespread availability, but recent research suggests it might be poised to make a huge difference. Paxlovid is an antiviral developed to target Covid-19 specifically by blocking a specific enzyme the virus needs to reproduce itself.
An interim analysis of an ongoing trial published by Pfizer last week noted that Paxlovid reduced the risk of hospitalization or death by 89 percent for adults at risk of severe Covid-19. That’s a huge effect size, and it’s always wise to be a little skeptical of results that good.
But if the studies hold up — and there are more ongoing that could support or refute the existing data — that could effectively mean the end of the pandemic. For many people, getting sick from Covid-19 would be much less of a danger.
Down the pike
There are many other early Covid-19treatments under development and in testing, too. For instance, researchers in the UK found that inhaled budesonide, a medication used to treat asthma, reduced recovery time, hospital admissions, and deaths in Covid-19 patients; studies are underway to confirm those results and to check how budesonide interacts with other early treatments.The antiviral remdesivir offers little benefit for Covid-19 patients and probably “makes little or no difference” in mortality, according to a systematic review of multiple studies on its effects. Gilead Sciences is developing a pill version for non-hospitalized patients in the hope that remdesivir might work better as an early treatment; some early evidencebears that out.
The FDA database of clinical trials for Covid-19 lists hundreds of studies on potential treatments, from repurposed medications to newly developed medicines to combination protocols of other promising drugs. The vast majority of those won’t pan out, but it only takes a few.
I suspect I’m not alone in being desperate for a return to normal — to concerts and indoor events, to in-person playdates for kids, for frictionless travel — while still being conscious of the fact that more than a thousand people are still dying of Covid-19 in the US every day.
The virus might be approaching endemicity, but those death counts needn’t become a new normal. By developing better at-home therapies, we can beat the disease back among both vaccinated people with breakthrough infections and individuals who have declined to be vaccinated. There’s some really good news here, and we owe a debt to the scientists who’ve worked to develop, test, and understand these drugs.
Are we turning the corner on Covid-19 treatments?
Covid-19 treatments are key to living with the virus. Here’s where we’re at.
www.vox.com
